DSK subsidiary Protox (CEO Lee Dong-beom) announced that it held a completion ceremony for a bio production plant at the Hyangnam Pharmaceutical Complex in Hwaseong-si, Gyeonggi-do on the 25th with approximately 200 Protox executives and employees and outsiders in attendance to develop botulinum toxin preparations.

The bio production plant began construction in May 2017 and was completed in about two years. A total project cost of approximately 32 billion won was invested to build a GMP (good manufacturing practice) facility with a total floor area of ​​6,227 m2 (approximately 1,886 pyeong) on ​​the 4th floor above ground.

With the completion of this factory, Protox will be able to produce 2.7 million vials of botulinum toxin preparations per year, and is undergoing redesign by installing additional freeze dryers to increase production to 5.4 million vials per year.

The company explained that it invested more than 10 billion won this year to install a German Bausch filling line that meets international standards for the first time in Korea in the GMP production line that produces botulinum toxin preparations, and that it has improved safety and efficiency by establishing an automated system for the entire production process. did.

Protox plans to complete GLP (good laboratory practice, animal testing norms) non-clinical testing of its self-developed botulinum toxin A preparation (tentative name Protoxin) at the end of this year and apply for clinical trial approval (IND).

A company official said, “With continued research and development and patent applications, we plan to export it to Southeast Asia and other countries next year and launch it domestically in 2022.”

Reporter Tak-soon Lee (hooggasi2@dailypharm.com)